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Completed

NCT Number: NCT00525512

Tiotropium In Exercise

The objective of this study is to evaluate the effects on exercise duration of 96 weeks treatment with 18 mcg tiotropium (Spiriva HandiHaler) daily as compared to placebo, in patients with COPD.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Behavior Chronic Disease Disease Attributes Exercise Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

205.368.54001 Boehringer Ingelheim Investigational Site, Rosario, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients must sign an informed consent
  • Diagnosis of COPD with specific spirometric criteria (determined at study visits)
  • Age >= 40 years
  • Medical Research Council Dyspnoea score >= 2
  • Current or ex-smoker with a >= 10 pack-year smoking history
  • Ability to exercise on treadmill

Exclusion criteria

  • Significant diseases other than COPD such as history of life-threatening pulmonary obstruction, thoracotomy with pulmonary resection, interstitial lung disease, CF, pulmonary thromboembolic disease, clinically evident bronchiectasis, active tuberculosis, or known moderate to severe renal impairment
  • Clinical history of asthma
  • Use of supplemental oxygen therapy
  • Respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3 (may randomize 6 weeks after recovery)
  • Recent history (<= 12 months) of myocardial infarction
  • Unstable or life-threatening cardiac arrhythmia
  • Malignancy treated with radiation therapy or chemotherapy in the last 5 years
  • Pregnant or nursing women
  • Known hypersensitivity to anticholinergic drugs or any component of the study medications
  • Participation in pulmonary or cardiac rehab program within 13 weeks of Visit 1
  • Estimated life expectancy < 2 years
  • Symptomatic prostatic hyperplasia or bladder neck obstruction
  • Known narrow-angle glaucoma
  • Any condition that is contraindicated for exercise
  • Orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing
  • Body mass index < 18 kg/m2 or >35 kg/m2 list truncated for space

Treatment and study plan

Tiotropium 18 mcg

Drug

Oral inhalation once daily of 18mcg tiotropium via handihaler

Placebo

Drug

Oral inhalation of once-daily placebo matching tiotropium via handihaler

Primary outcomes

  1. 90% Constant Work Rate (CWR) Treadmill Endurance Time at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

Secondary outcomes

  1. 90% Constant Work Rate (CWR) Treadmill Endurance Time at 8 Weeks - Double-Blind Phase

    Time frame: baseline, 8 weeks

    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  2. 90% Constant Work Rate (CWR) Treadmill Endurance Time at 16 Weeks - Double-Blind Phase

    Time frame: baseline, 16 weeks

    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  3. 90% Constant Work Rate (CWR) Treadmill Endurance Time at 32 Weeks - Double-Blind Phase

    Time frame: baseline, 32 weeks

    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  4. 90% Constant Work Rate (CWR) Treadmill Endurance Time at 48 Weeks - Double-Blind Phase

    Time frame: baseline, 48 weeks

    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  5. 90% Constant Work Rate (CWR) Treadmill Endurance Time at 64 Weeks - Double-Blind Phase

    Time frame: baseline, 64 weeks

    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  6. 90% Constant Work Rate (CWR) Treadmill Endurance Time at 80 Weeks - Double-Blind Phase

    Time frame: baseline, 80 weeks

    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  7. Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase

    Time frame: baseline, 8 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  8. Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase

    Time frame: baseline, 16 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  9. Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase

    Time frame: baseline, 32 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  10. Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase

    Time frame: baseline, 48 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  11. Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase

    Time frame: baseline, 64 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  12. Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase

    Time frame: baseline, 80 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  13. Pre-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  14. Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 8 Weeks - Double-Blind Phase

    Time frame: baseline, 8 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  15. Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 16 Weeks - Double-Blind Phase

    Time frame: baseline, 16 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  16. Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 32 Weeks - Double-Blind Phase

    Time frame: baseline, 32 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  17. Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 48 Weeks - Double-Blind Phase

    Time frame: baseline, 48 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  18. Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 64 Weeks - Double-Blind Phase

    Time frame: baseline, 64 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  19. Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 80 Weeks - Double-Blind Phase

    Time frame: baseline, 80 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  20. Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  21. Pre-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase

    Time frame: baseline, 8 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  22. Pre-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase

    Time frame: baseline, 16 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  23. Pre-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase

    Time frame: baseline, 32 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  24. Pre-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase

    Time frame: baseline, 48 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  25. Pre-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase

    Time frame: baseline, 64 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  26. Pre-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase

    Time frame: baseline, 80 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  27. Pre-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  28. Post-treatment Forced Vital Capacity (FVC) at 8 Weeks - Double-Blind Phase

    Time frame: baseline, 8 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  29. Post-treatment Forced Vital Capacity (FVC) at 16 Weeks - Double-Blind Phase

    Time frame: baseline, 16 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  30. Post-treatment Forced Vital Capacity (FVC) at 32 Weeks - Double-Blind Phase

    Time frame: baseline, 32 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  31. Post-treatment Forced Vital Capacity (FVC) at 48 Weeks - Double-Blind Phase

    Time frame: baseline, 48 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  32. Post-treatment Forced Vital Capacity (FVC) at 64 Weeks - Double-Blind Phase

    Time frame: baseline, 64 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  33. Post-treatment Forced Vital Capacity (FVC) at 80 Weeks - Double-Blind Phase

    Time frame: baseline, 80 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  34. Post-treatment Forced Vital Capacity (FVC) at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  35. Borg Scale of Dyspnea at Isotime After 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

  36. Borg Scale of Peak Dyspnea After 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

  37. Borg Scale of Peak Leg Discomfort After 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    Borg scale assessed degreee of discomfort on a scale from 0 (Nothing at all) to 10 (Maximal)

  38. Change From Baseline in Physician Global Evaluation at 8 Weeks - Double-Blind Phase

    Time frame: baseline, 8 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  39. Change From Baseline in Physician Global Evaluation at 16 Weeks - Double-Blind Phase

    Time frame: baseline, 16 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  40. Change From Baseline in Physician Global Evaluation at 32 Weeks - Double-Blind Phase

    Time frame: baseline, 32 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  41. Change From Baseline in Physician Global Evaluation at 48 Weeks - Double-Blind Phase

    Time frame: baseline, 48 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  42. Change From Baseline in Physician Global Evaluation at 64 Weeks - Double-Blind Phase

    Time frame: baseline, 64 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  43. Change From Baseline in Physician Global Evaluation at 80 Weeks - Double-Blind Phase

    Time frame: baseline, 80 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  44. Change From Baseline in Physician Global Evaluation at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  45. Change From Baseline in Patient Global Evaluation at 8 Weeks - Double-Blind Phase

    Time frame: baseline, 8 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  46. Change From Baseline in Patient Global Evaluation at 16 Weeks - Double-Blind Phase

    Time frame: baseline, 16 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  47. Change From Baseline in Patient Global Evaluation at 32 Weeks - Double-Blind Phase

    Time frame: baseline, 32 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  48. Change From Baseline in Patient Global Evaluation at 48 Weeks - Double-Blind Phase

    Time frame: baseline, 48 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  49. Change From Baseline in Patient Global Evaluation at 64 Weeks - Double-Blind Phase

    Time frame: baseline, 64 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  50. Change From Baseline in Patient Global Evaluation at 80 Weeks - Double-Blind Phase

    Time frame: baseline, 80 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  51. Change From Baseline in Patient Global Evaluation at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    The evaluation represented the global opinion of the overall clinical condition on a scale of: 1-2 (Poor), 3-4 (Fair), 5-6 (Good), 7-8 (Excellent)

  52. Saint George's Respiratory Questionnaire Total Score at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  53. Saint George's Respiratory Questionnaire Activity Component Score at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  54. Saint George's Respiratory Questionnaire Impact Component Score at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  55. Saint George's Respiratory Questionnaire Symptoms Component Score at 96 Weeks - Double-Blind Phase

    Time frame: baseline, 96 weeks

    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  56. Patients With COPD Exacerbation (Survival Analysis) - Double-Blind Phase

    Time frame: baseline, 96 weeks

    COPD exacerbation is a complex of symptoms related to COPD with a duration of three days or more requiring a change of treatment.

  57. 90% Constant Work Rate (CWR) Treadmill Endurance Time at 100 Weeks - Open-Label Phase

    Time frame: baseline, 100 weeks

    Efficacy was assessed by measuring the exercise duration during a treadmill exercise test.

  58. Post-treatment Forced Expiratory Volume in 1 Second (FEV1) at 100 Weeks - Open-Label Phase

    Time frame: baseline, 100 weeks

    FEV1 is the maximal amount of air you can forcefully exhale in one second.

  59. Post-treatment Forced Vital Capacity (FVC) at 100 Weeks - Open-Label Phase

    Time frame: baseline, 100 weeks

    FVC is the volume of air that can be forcibly blown out after full inspiration.

  60. Saint George's Respiratory Questionnaire Total Score at 100 Weeks - Open-Label Phase

    Time frame: baseline, 100 weeks

    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  61. Saint George's Respiratory Questionnaire Activity Component Score at 100 Weeks - Open-Label Phase

    Time frame: baseline, 100 weeks

    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  62. Saint George's Respiratory Questionnaire Impact Component Score at 100 Weeks - Open-Label Phase

    Time frame: baseline, 100 weeks

    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  63. Saint George's Respiratory Questionnaire Symptoms Component Score at 100 Weeks - Open-Label Phase

    Time frame: baseline, 100 weeks

    Score summarises the impact of disease on overall health status with zero indicating best health status and 100 indicating worst possible health status.

  64. Clinical Relevant Abnormalities for Vital Signs and Physical Examination, Including Vital Status

    Time frame: From first drug administration until 30 days after last drug administration

    Clinical Relevant Abnormalities for Vital Signs and Physical examination, including vital status. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Events.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Two-year Trial to Examine the Changes in Exercise Endurance and COPD Treated With Tiotropium Once Daily (EXACTT)

Important dates

Study start
2007
Primary completion
2010
First posted
Sep 5, 2007
Registry last updated
Dec 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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